Slovak Financial Law News 2004

Order on Requirements of Clinical Testing and Correct Clinical Practise

Order of the Ministry of Health of the Slovak Republic No. 239/2004 Coll. on Requirements of Clinical Testing and Correct Clinical Practise

This order stipulates requirements of clinical testing and correct clinical practise, but it does not regulate the non-interventional clinical testing.

The pharmaceutical testing and toxicological-pharmacological testing made upon particular law (decree of the Ministry of Health the Slovak Republic No. 275/1998 Coll. on Pharmaceutical Testing and Toxicological-Pharmacological Testing) has to precede the clinical testing.

A health institution establishing a workplace submits an application for approval of the workplace for performance of clinical testing to the State Institute for Drug Control. The application for the workplace approval may be submitted together with an application for the permit of clinical testing.

Documentation on results of clinical testing required together with submission of the application for the drug/medicine registration shall contain all results of all clinical testing performed with either positive or negative result of analysis.

This Order came into force on 1 May 2004.